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510(k) K223635

Device
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
Applicant
Sienco, Inc.
510(k) number
K223635
Product code
JBP
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-04
Date received
2022-12-05
Regulation
864.7140
Classification name
Activated Whole Blood Clotting Time
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jennifer Aiken
Address
5721 Arapahoe Ave., Unit A1-A Boulder CO US 80303 80303

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JBP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K062604RAPIDTEG TEG-ACT TESTHaemoscope Corp.2007-01-31
K032952AIACT KITSienco, Inc.2003-12-12
K023582I-STAT KAOLIN ACT TESTI-Stat Corporation2003-09-08
K020914ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770Helena Laboratories2002-05-23
K013078ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752Helena Laboratories2002-01-10
K002528SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTIONSienco, Inc.2000-08-31
K994194(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINTCardiovascular Diagnostics, Inc.2000-03-28
K992571I-STAT SYSTEMI-Stat Corp.2000-02-10
K992851ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEMRoche Diagnostics Corp.2000-01-14
K984141GBACT + KITSienco, Inc.1999-05-28
K983649MAX-ACTArray Medical, Inc.1998-12-11
K971935B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)B & D Corp.1997-10-01
K964609ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBEArray Medical, Inc.1997-03-06
K960749HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACTInternational Technidyne Corp.1996-08-12
K941007CATALOG NO. J-ACT+ & QC-ACT+International Technidyne Corp.1994-06-30